1. Field of the Invention
The invention relates to a method and a device for conducting an integrity test on a flexible test container.
2. Description of the Related Art
Hermetically sealed flexible bags, such as plastic bags, are often used particularly in bioprocessing. In many applications, flexible bags are used for accommodating cell culture solutions, blood reserves, solutions for bioreactors, etc. In particular in bioprocessing, use is often made of sterilized containers that are to remain sterile during use.
In order to be able to detect a damaged container, which is thus unsuitable for sterile use, the flexible container may be subjected to leak testing and/or integrity testing prior to its use. Here, a flexible test container to be inspected is filled with an examination gas and arranged in a sealable examination container. A vacuum is created in the examination container. If the test container has a leak, the examination gas will pass through the leak, due to the pressure difference between the test container and the examination container, and can be detected in the examination container.
If no examination gas is detected in the examination container, the test container will pass the leak test and/or integrity test. If examination gas is detected in the examination container, the test container is not suitable for use as a sterile container.
It is the object of the invention to improve the performance of an integrity test on a flexible test container.
The object is solved by the subject matters of the independent claims. The dependent claims relate to preferred embodiments.